Cleared Traditional

K960674 - CONTRAST INJECTION LINES

K960674 is the FDA 510(k) clearance for CONTRAST INJECTION LINES by B.Braun Medical, Inc.. It is a Class 2 Cardiovascular device (product code DXT) cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K960674 · B.Braun Medical, Inc. · Cardiovascular device
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Sep 1996
Decision
212d
Days
Class 2
Risk

K960674 is an FDA 510(k) clearance for the CONTRAST INJECTION LINES. Classified as Injector And Syringe, Angiographic (product code DXT), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on September 19, 1996 after a review of 212 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all B.Braun Medical, Inc. devices

Submission Details

510(k) Number K960674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1996
Decision Date September 19, 1996
Days to Decision 212 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 125d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXT Injector And Syringe, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXT Injector And Syringe, Angiographic

All 101
Devices cleared under the same product code (DXT) and FDA review panel - the closest regulatory comparables to K960674.
MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)
K973230 · Merit Medical Systems, Inc. · Nov 1997
MEDRAD DISPOSABLE SYRINGES
K964642 · Medrad, Inc. · Apr 1997
VOLUME CONTROL SYRINGE MODEL VCD-SYR-10
K962141 · B.Braun Medical, Inc. · Mar 1997
B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT
K955381 · B.Braun Medical, Inc. · Feb 1996
MEDRAD SPECTRIS MR INJECTOR
K935668 · Medrad, Inc. · Sep 1995
SCIMED ENCORE ADVANTAGE KIT AND THE ESSENTIALS KIT
K951802 · Scimed Life Systems, Inc. · Jul 1995